EUCTR2021-000319-21-DE进行中（未招募）1 期
Treating Nightmares in Posttraumatic Stress Disorder with the a-adrenergic Agents Clonidine and Doxazosin: A Randomized-Controlled Feasibility Study (ClonDoTrial) - ClonDoTrial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 189
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Diagnosis of posttraumatic stress disorder (PTSD) according to DSM 5 with a 20 item CAPS-5 total score = 26
- •2.At least two nightmares a week, an intensity score = 2, with a CAPS-IV B2 (frequency and intensity for the last week) score = 5
- •3.Men and women between 18 and 65 years of age
- •4.Written informed consent
- •5.The patient has the capacity to give consent (He/she is able to understand the nature and anticipated effects/side effects of the proposed medical intervention)
- •6.The patient is not breastfeeding
- •7.Women of child-bearing potential must have a negative urine or serum pregnancy test
- •8.All participants must use highly effective contraception
- •9. The patient received stable pharmacological medication for at least 4 weeks or at least five times the value of a elimination half-life prior to study baseline (any changes in medication dose or frequency of therapy must be answered with no)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 189
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Disturbances of cardiac impulse formation and conduction, for example sick sinus syndrome or atrioventricular block second and third degree
- •2.Bradycardia, with a heart rate less than 50 beats per minute
- •3.Current major depressive episode and a MADRS score > 34
- •4.The patient does have a known allergy, hypersensitivity or contraindication against clonidine, doxazosin, or other types of quinazolines
- •5.History of severe orthostatic hypotension
- •6.Benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones, hypotension (for benign prostate hyperplasia only)
- •7.Either overflow bladder or anuria with or without progressive renal insufficiency
- •8.Planned cataract surgery (risk of 'Intraoperative Floppy Iris Syndrome')
- •9.Intake of phosphodiesterase-5-inhibitors
- •10.Intake of methylphenidate
- •11.Severe hepatic impairment (ASAT or ALAT greater than two times normal)
- •12.Acute or unstable medical illness
- •13.Known HIV- and/or active Hepatitis-B- or Hepatitis-C-infection
- •14.Current or past malignant illness
- •15.The patient does have clinically significant abnormalities in 12-lead ECG
- •16.The patient does have clinically significant laboratory abnormalities
- •17.Epilepsy
- •18.Dementia
- •19.Current substance/alcohol use disorder (= 3 months)
- •20.Psychotic disorder
- •21.Bipolar disorder
- •22.Current anorexia nervosa
- •23.Acute suicidality (any suicidal ideation of type of 5 in the C-SSRS in the past month)
- •24.Intake of alpha adrenergic agents (Clonidine, doxazosin, or others) within 4 weeks prior to baseline (randomization)
- •25.Trauma-focused psychotherapy four weeks before the trial
- •26.Initiation of sleep medication 4 weeks prior to baseline
- •27.The patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons
- •28.Patients, who may be dependent on the sponsor, the investigator or the trial sites
- •29.The patient is legally detained in an official institution
- •30.The patient did participated in other interventional trials during the 3 months before and at the time of this trial
研究者
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